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Checkpoint Inhibitor

Tumor-Treating Fields + Immunotherapy for Uveal Melanoma

Phase 1
Recruiting
Led By Justin Moser, MD
Research Sponsored by HonorHealth Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
Normal organ and marrow function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initiation of study treatment and through study completion, up to 1 year
Awards & highlights

Study Summary

This trial suggests that Tumor Treating Fields may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.

Who is the study for?
This trial is for adults with metastatic uveal melanoma, mainly affecting the liver. Participants must be in good physical condition (ECOG 0-1), have a life expectancy of at least 3 months, and normal organ/marrow function. Women of childbearing potential must test negative for pregnancy and use contraception. Excluded are those with active autoimmune diseases requiring strong medication, recent cancer treatments, or severe reactions to immune checkpoint inhibitors.Check my eligibility
What is being tested?
The study tests Tumor-Treating Fields targeting liver metastases combined with Nivolumab and Ipilimumab—two immunotherapy drugs—in patients with metastatic uveal melanoma. The goal is to see if this combination improves patient outcomes compared to current treatments.See study design
What are the potential side effects?
Possible side effects include skin irritation from the device used for Tumor-Treating Fields, as well as typical immune therapy-related issues like inflammation in organs, fatigue, digestive problems, skin reactions and potential worsening of autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of eye melanoma that has spread mainly to my liver.
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My organs and bone marrow are functioning normally.
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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of study treatment and through study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of study treatment and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Overall Safety
Secondary outcome measures
Overall Survival Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: TTF Plus ChemotherapyExperimental Treatment3 Interventions
Novacure Optune with Opdivo and Yervoy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yervoy
2012
Completed Phase 2
~700
Opdivo
2017
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,722 Total Patients Enrolled
HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
896 Total Patients Enrolled
Justin Moser, MDPrincipal InvestigatorHonorHealth Research Institute
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Uveal Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05004025 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for participation in the clinical trial?

"This medical study is open to participants aged 18-100. Additionally, they have opened 108 clinical trials specifically for those under the age of consent and 1491 such studies are available to patients over 65 years old."

Answered by AI

What indications does Opdivo typically address?

"Opdivo is widely used to treat the effects of angiogenesis and can also be utilised in cases with malignant neoplasms, advanced melanomas, and squamous cell carcinoma."

Answered by AI

Are there any opportunities to join this experiment at the present time?

"Affirmative. Clinicaltrials.gov information indicates that this trial is actively enrolling participants, with the initial posting appearing on February 28th 2022 and most recent updates occurring March 21st of the same year. The study needs 10 patients from a single location to move forward."

Answered by AI

Can you please elucidate on earlier studies that have utilized Opdivo in their research?

"Presently, 764 studies are actively researching the efficacy of Opdivo. Of those trials, 86 are in their final phase. Most tests for this treatment occur at Pittsburgh-based locations; nonetheless, there are 42760 sites hosting clinical trials worldwide."

Answered by AI

How many individuals have volunteered to contribute data in this experiment?

"Affirmative, clinicaltrials.gov's records demonstrate that recruitment is still in progress for this medical trial which was initially posted on February 28th 2022 and recently modified on March 21st 2022. The study requires 10 volunteers to be enrolled from a single site."

Answered by AI

What evidence is available to demonstrate the security of Opdivo for human use?

"As this is still a Phase 1 study, our team at Power believes that the safety of Opdivo ranks as a 1 out of 3 due to there being limited data backing its efficacy and safety."

Answered by AI

Is my eligibility for the experiment under consideration?

"This clinical study is recruiting 10 adults (18 years or older) suffering from metastatic uveal melanoma, mainly in the liver. To be eligible for participation, applicants must meet a series of criteria such as being able to provide informed consent, having normal organ and marrow functions, ECOG 0-1 score and have a minimum life expectancy of 3 months. Moreover, women of childbearing potential need to perform a negative pregnancy test 72 hours prior to their first administration of the drug and both patient and partner must agree on utilizing an reliable form of contraception if actively sexually involved."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
65+
What site did they apply to?
HonorHealth Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
2022. "Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05004025.
~4 spots leftby Aug 2025
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